BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE

    MDR report key: 823580 · Received January 31, 2007

    Report

    Report Number
    3002807968-2007-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 31, 2007
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LNX
    PMA / PMN Number
    k050869
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL BULLETIN (SERVICE TIP) WILL BE ISSUED IN ORDER TO NOTICE IT SPECIALISTS NOT TO CHANGE THE PRIMARY STORAGE METHOD WITHOUT REMOVING ALL RESULTS. ADDITIONALLY TRAINING OF THE IT SPECIALISTS WILL BE PERFORMED. ADD'L CATALOG# 914-426.

    Description of Event or Problem · 1

    RADIANCE IS USED AS A DATA EXCHANGE AND PROCESSING INTERFACE BETWEEN A BLOOD GAS ANALYZER AND THE HOSPITAL OR LABORATORY INFORMATION SYSTEM (HLIS). FOR THE RADIANCE SOFTWARE VERSION #2.62, WE HAVE IDENTIFIED A PROBLEM IN THE SOFTWARE, WHICH MAY CAUSE RESULTS TO BE HANDLED INCORRECTLY. A CUSTOMER PRINTED A PATIENT REPORT, AND NOTICED THAT A PREVIOUS RESULT WAS MISSING FROM THE HISTORY SECTION OF THE PATIENT REPORT. REVIEWING THE DATA MANAGEMENT FILE FOR THE PATIENT SHOWED THAT THE MISSING RESULT WAS ASSOCIATED TO ANOTHER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE LABORATORY INFORMATION MANAGEMENT SYSTEM LNX RADIOMETER MEDICAL APS RADIANCE V. 2.62 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA